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Device Explorer · FDA GUDID · GMDN 40867

CT system application software

An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routine

US‑registered devices85in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Siemens Healthcare Gmbh2529%
Mindways Software, Inc.1214%
Ge Medical Systems, L.L.C.911%
Ge Healthcare Japan Corporation78%
Auris Health, Inc.67%
Circle Cardiovascular Imaging Inc45%
Icad, Inc.45%
Vida Diagnostics, Inc.34%

Top labelers

CompanyDevicesShare
Siemens Healthcare Gmbh2529%
Mindways Software, Inc.1214%
Ge Medical Systems, L.L.C.911%
Ge Healthcare Japan Corporation78%
Auris Health, Inc.67%
Circle Cardiovascular Imaging Inc45%
Icad, Inc.45%
Vida Diagnostics, Inc.34%
4Dmedical Limited34%
Imvaria Inc.34%
Optellum Ltd22%
Medic Vision - Imaging Solutions Ltd11%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SafeCTsyngo.CT Coronary CockpitAI-Rad Companion (Pulmonary)syngo.CT Dual EnergyUpdate Label 127046syngo.CT Brain Hemorrhagesyngo.via RT Image Suitesyngo.CT ApplicationsAI-Rad Companion (Musculoskeletal)AI-Rad Companion (Cardiovascular)syngo.CT CaScoringsyngo.CT Extended Functionalitysyngo.CT Skull UnfoldingAI-Rad Companion (Engine)StrokeSENS LVOTruPlan

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JAKSystem, x-ray, tomography, computed32
JAKSystem, X-Ray, Tomography, Computed20
KGIDensitometer, Bone13
QIHAutomated Radiological Image Processing Software8
LLZSystem, image processing, radiological8
LLZSystem, Image Processing, Radiological6

GMDN & GCC registration

  • GMDN code 40867 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 79% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many ct system application software products are registered in the US?

85 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CT system application software", from 18 companies. The largest labeler is Siemens Healthcare Gmbh with 29% of records.

Which FDA product codes apply?

JAK (System, x-ray, tomography, computed), JAK (System, X-Ray, Tomography, Computed), KGI (Densitometer, Bone), QIH (Automated Radiological Image Processing Software)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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